NCT04258137Active, not recruiting
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients. For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B: * Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis) * Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 332 (estimated)
- First submitted
- 4 Feb 2020
- Start date
- 4 Sept 2020
- Primary completion date
- 24 May 2027
- Lead sponsor
- Institut Bergonié
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT04258137
What you commit to
- Study type: Interventional
- Planned participants: 332
- From 4 Sept 2020 to the primary completion date, 24 May 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allogeneic bone marrow transplant,
- Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
- Previous enrolment in the present study,
- Any contraindication to first-line systemic therapy.
Other illness
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
Other
- Inability to swallow,
- Major problem with intestinal absorption,
- Individuals deprived of liberty or placed under guardianship,
- Pregnant or breast feeding women,
Who the study is looking for
- Age ≥ 18 years,
- Histology: colorectal cancer, non-small cell lung cancer,
- Locally advanced/unresectable and/or metastatic solid tumor,
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1),
- Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally \> 10 mm,
- No previous systemic treatment for advanced disease,
- Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,
- Eligible to first-line systemic therapy,
- Patient with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Polyclinique Bordeaux Nord Aquitaine Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Polyclinique Marzet Coordinator of this site? Confirm its status | Pau | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.